FDA 483 - Catalent Belgium SA - July 07, 2017

Catalent Belgium, SA received an FDA Form 483 following an inspection from June 29 to July 7, 2017, detailing several deviations from Current Good Manufacturing Practices (CGMP). The primary issues centered on a failure to thoroughly investigate unexplained discrepancies, including unaddressed HEPA filter leaks and five out-of-specification product results lacking an overarching investigation. The inspection also identified inadequate validation of sterilization processes, specifically concerning biological indicator incubation practices. Furthermore, unauthorized personnel had access to finished product label storage areas.

The company's automated visual inspection system for defects was found insufficient, as validations assessed broad defect families rather than individual defect sub-categories. Environmental condition monitoring in the Quality Control laboratory and warehouse was inadequate, potentially allowing undetected temperature excursions. Equipment maintenance was deficient, with observations including a cracked light cover, etched sight glasses, and a damaged visual inspection tool. Finally, raw materials were dispensed into secondary containers without a written evaluation to prevent contamination. Catalent is required to implement comprehensive corrective and preventive actions to address these observations and ensure compliance with regulatory standards.